Phase
Condition
Thrombosis
Venous Thromboembolism
Lung Disease
Treatment
Thrombectomy
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 and ≤ 80 years
Subject or legally authorized representative (LAR) is willing and able to providewritten informed consent prior to receiving any non-standard of care protocolspecific procedures
Subject is willing and able to comply with all protocol required follow-up visits
PE symptom(s) duration ≤ 14 days from index procedure
PE diagnosis ≤ 48 hours prior to index procedure
CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonaryartery based on Investigator determination)
CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based onInvestigator determination
Systolic blood pressure ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior toindex procedure)
Stable heart rate < 130 BPM prior to index procedure
Subject is deemed medically eligible for interventional procedure(s), perinstitutional guidelines and clinical judgment
Exclusion
Exclusion Criteria:
Prior PE ≤ 180 days from index procedure
Current hospitalization for other condition(s)
Thrombolytic use ≤ 14 days of baseline CTA
Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg byright heart catheterization
FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
Hematocrit < 28% within 6 hours of index procedure
Platelets < 100,000/μL
Serum creatinine > 1.8 mg/dL
International normalized ratio (INR) > 3
Presence of intracardiac lead in the right ventricle or right atrium placed < 180days prior to index procedure
Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
Actively progressing cancer treated by chemotherapeutics
Known bleeding diathesis or coagulation disorder
Left bundle branch block
History of severe or chronic pulmonary arterial hypertension
History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
History of uncompensated heart failure
History of underlying lung disease that is oxygen dependent
History of chest irradiation
History of heparin-induced thrombocytopenia (HIT)
Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
Known anaphylactic reaction to radiographic contrast agents that cannot bepretreated
Imaging evidence or other evidence that suggests, in the opinion of theInvestigator, the Subject is not appropriate for aspiration thrombectomyintervention such as the inability to navigate to target location, predominantlychronic clot or non-clot embolus
Life expectancy of < 90 days, as determined by Investigator
Female who is pregnant or nursing
Current participation in another investigational drug or device treatment study thathas not reached the primary endpoint or the Investigator feels would impact theirability to participate in this clinical trial
Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
Subject on extracorporeal membrane oxygenation (ECMO)
Study Design
Connect with a study center
Honor Health
Scottsdale, Arizona 85258
United StatesSite Not Available
NorthBay Medical Center
Fairfield, California 94533
United StatesSite Not Available
MemorialCare
Long Beach, California 90806
United StatesSite Not Available
El Camino Health
Mountain View, California 94040
United StatesSite Not Available
Sutter Health
Sacramento, California 95816
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06102
United StatesSite Not Available
Medstar
Washington, District of Columbia 20010
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Alexian Brothers Medical Center
Elk Grove Village, Illinois 60007
United StatesSite Not Available
Ascension Illinois
Elk Grove Village, Illinois 60007
United StatesActive - Recruiting
Ascension St. Vincent
Indianapolis, Indiana 46260
United StatesSite Not Available
Ochsner Health
New Orleans, Louisiana 70121
United StatesSite Not Available
McLaren Health Care
Bay City, Michigan 48708
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Ascension Providence
Southfield, Michigan 48075
United StatesSite Not Available
CentraCare Heart and Vascular
Saint Cloud, Minnesota 56303
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesSite Not Available
Ichan School of Medicine at Mount Sinai
New York, New York 10019
United StatesSite Not Available
University Hospitals
Cleveland, Ohio 44106
United StatesSite Not Available
OhioHealth Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
ProMedica - Jobst Vascular
Toledo, Ohio 43606
United StatesSite Not Available
Ascension St. John
Tulsa, Oklahoma 74006
United StatesSite Not Available
The Miriam Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
Centennial Medical Center (HCA)
Nashville, Tennessee 37203
United StatesSite Not Available
Ascension Seton
Austin, Texas 78705
United StatesSite Not Available
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